Device recall

Z-0588-05: Vistabritetip IG Introducer, Introducer Guide. Labeled as sterile, sterilized…

FDA device recall · Class III · Cordis Corporation

Key facts

Recall number (Z-number) Z-0588-05
Recall event 29574
Product Vistabritetip IG Introducer, Introducer Guide. Labeled as sterile, sterilized with ethylene oxide gas. For single use only. Catalog number 4038553S
Product code DQY
Recalling firm Cordis Corporation
Recall class Class III
Status Terminated
Termination date Nov 21, 2008
510(k) numbers K001136
FEI number 1016427

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)